Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated is
indicated for the control of spontaneous bleeding episodes or to cover surgical
interventions in hemophilia A and B patients with inhibitors.
In addition, the use of Anti-Inhibitor Coagulant Complex, Feiba
Immuno has been described in a few non-hemophiliacs with acquired inhibitors
to Factors VIII,XI, and XII8-12.One case has been reported where
Anti-Inhibitor Coagulant Complex, Feiba Immuno was effective in a patient with
von Willebrand’s disease with an inhibitor16.
Clinical experience suggests that patients with a Factor VIII
inhibitor titer of less than 5 B.U. may be successfully treated with Antihemophilic
Factor. Patients with titers ranging between 5 and 10 B.U.may either be treated
with Antihemophilic Factor or Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor
Heated. Cases with Factor VIII inhibitor titers greater than 10 B.U. have generally
been refractory to treatment with Antihemophilic Factor.
Inadequate response to treatment may result from an abnormal
platelet count or impaired platelet function13-15 which were present
before treatment with Anti-Inhibitor Coagulant Complex,Feiba VH,Vapor Heated.
DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter
and discoloration prior to administration, whenever solution and container permit.Clinical
trials5-7 have demonstrated that the response to treatment with Anti-Inhibitor
Coagulant Complex, Feiba Immuno, may differ from patient to patient with no
correlation to the patient’s inhibitor titer. Response may also vary between
different types of hemorrhage (e.g.joint hemorrhage vs. CNS hemorrhage).As a
general guideline a dosage range of 50 to 100 IMMUNO Units of Anti-Inhibitor
Coagulant Complex, Feiba VH, Vapor Heated per kg of body weight is recommended.
However, care should be taken to distinguish between the following four indications,
all of which have undergone careful clinical evaluation:
Joint Hemorrhage
In joint hemorrhage, a dose of 50 units per kg of body weight
is recommended at 12-hour intervals, which may be increased to doses of 100
units per kg of body weight at 12-hour intervals. Treatment should be continued
until clear signs of clinical improvement appear, such as relief of pain,
reduction of swelling or mobilization of the joint.
Mucous Membrane Bleeding
A dose of 50 units per kg of body weight is recommended to
be given at 6-hour intervals under careful monitoring (visible bleeding site,
repeated measurements of the patient’s hematocrit).Again, if hemorrhage does
not stop, the dose may be increased to 100 units per kg of body weight at
6-hour intervals.However,2 such administrations or 200 units per kg of body
weight a day should not be exceeded.
Soft Tissue Hemorrhage
For serious soft tissue bleeding, such as retroperitoneal
bleeding, doses of 100 units per kg of body weight at 12-hour intervals are
recommended. A daily dosage of 200 units per kg of body weight should not
be exceeded.
Other Severe Hemorrhages
Severe hemorrhages, such as CNS bleedings have been effectively
treated with doses of 100 units per kg of body weight at 12-hour intervals.
Sometimes, Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated may be
indicated at 6-hour intervals until clear clinical improvement is achieved.
Reconstitution
1. Warm the unopened bottle containing Sterile
Water for Injection (diluent) to room temperature (not above 37°C,98°F).
2. Remove caps from the concentrate and diluent
bottles to expose central portions of the rubber stoppers.
3. Cleanse exposed surface of the rubber stoppers
with germicidal solution and allow to dry.
4. Using aseptic technique, remove protective
covering from one end of the double-ended needle, and completely insert
the exposed end through the diluent bottle stopper.
5. Remove protective covering from the other end
of the double-ended needle, taking care not to touch the exposed end.
Invert diluent bottle over the concentrate bottle, then rapidly insert
free end of the needle to its full length through the concentrate
bottle stopper. Diluent will be drawn into the concentrate bottle
by vacuum.
6. Disconnect the two bottles by removing needle
from the concentrate bottle stopper. Gently agitate or rotate the
concentrate bottle until all material is dissolved.
Do not refrigerate after reconstitution! After complete reconstitution
of Anti-Inhibitor Coagulant Complex, Feiba VH, Vapor Heated, its injection
or infusion should be commenced as promptly as practicable, but must be
completed within three hours following reconstitution.The solution must
be given by intravenous injection or intravenous drip infusion and the
maximum injection or infusion rate must not exceed 2 units per kg of body
weight per minute. In a patient with a body weight of 75 kg, this corresponds
to an infusion rate of 2.5 –7.5 mL per minute depending on the number
of units per vial (see label on vial).
For Intravenous Injection:
1. After reconstituting the concentrate as described
under Reconstitution, attach the enclosed filter needle to a sterile
disposable syringe .Insert filter needle through the concentrate bottle
stopper.
2. Inject air and withdraw solution into the syringe.
3. Remove and discard the filter needle. Attach a suitable
intravenous needle or infusion set with winged adapter, and inject solution
intravenously.
For Intravenous Infusion:Prepare a solution of Anti-Inhibitor Coagulant
Complex, Feiba VH, Vapor Heated as described under Reconstitution. Follow
manufacturer’s instructions for the administration set used.Make sure that the
set contains an adequate filter.
HOW SUPPLIED
Anti-Inhibitor
Coagulant Complex, Feiba VH, Vapor Heated is supplied as freeze-dried powder,
accompanied by a suitable volume of Sterile Water for Injection, U.S.P.(This
Product Contains Dry Natural Rubber.),a sterile double-ended needle, and a sterile
filter needle.The number of IMMUNO Units of Factor VIII inhibitor bypassing
activity is stated on the label of each bottle.STORAGEStore at refrigerator
temperature (2° to 8°C,35° to 46°F).Avoid freezing, which may damage the
diluent bottle.
REFERENCES
1. ELSINGER F.:Aktivierter Faktor VII in Prothrombinkomplex-Konzentraten.23rd
Annual Meeting of "Deutsche Arbeitsgemeinschaft für Blutgerinnungsforschung"
(DAB),Heidelberg,1979.F.K.Schattauer Verlag, Stuttgart-New York,367,1980.
2. SELIGSOHN U., ØSTERUD B.,RAPAPORT S.I.: Coupled
Amidolytic Assay for Factor VII: Its Use With a Clotting Assay to Determine
the Activity State of Factor VII. Blood 52:978,1978.
3. SELIGSOHN U.,KASPER C.K., ØSTERUD B.,RAPAPORT
S.I.: Activated Factor VII: Presence in Factor IX Concentrates and Persistence
in the Circulation After Infusion. Blood 53:828,1979.
4. MANNUCCI P.M.: Personal communication
5. SJAMSOEDIN L.J.M.,HEIJNEN L.,MAUSER-BUNSCHOTEN E.P.,
van GEIJLSWIJK J.L., van HOUWELIN-GEN H., van ASTEN P.,SIXMA J.J.: The Effect
of Activated Prothrombin-Complex Concentrate (FEIBA) on Joint and Muscle
Bleeding in Patients with Hemophilia A and Antibodies to Factor VIII. The
New Engl.J. of Med.305:717,1981.
6. ROBERTS H.R.: Hemophiliacs with Inhibitors: Therapeutic
Options. The New Engl.J. of Med.305:757,1981.
7. HILGARTNER M.W.,KNATTERUD G.AND THE FEIBA STUDY GROUP:
The Use of Factor-Eight-Inhibitor-By-Passing-Activity (FEIBA IMMUNO) Product
for Treatment of Bleeding Episodes in Hemophiliacs with Inhibitors. Blood
61:36,1983.
8. THOMAS T.,WILLIAMS H.,WILLIAMS Y.,HUNT J.:FEIBA in
Haemophiliacs with Factor VIII Inhibitor.Brit.Med.J.1:52,1977.
9. ROLOVIC Z.,ELEZOVIC I.,OBRENOVIC B.: Life-Threatening
Bleeding Due to an Acquired Inhibitor to Factor XII–XI Successfully Treated
with FEIBA. Proceedings of Joint Meeting of the 18th Congress of the International
Society of Hematology and 16th Congress of the International Society of
Blood Transfusion, Montreal. Abstract 703,1980.
10. DORMANDY K.: Unpublished data.
11. VINAZZER H.: Personal communication.
12. PRESTON F.E.:A Review of Cases Treated with FEIBA
in 1977/78.Presentation at the Second Workshop on Factor VIII Inhibitor
Patients,Vienna,1979.
13. VERMYLEN J.,SCHETZ J.,SEMERARO N.,MERTENS F.,VERSTRAETE
M.: Evidence that ‘Activated’ Prothrombin Concentrates Enhance Platelet
Coagulant Activity.Brit.J.Haematol.38:235,1978.
14. SEMERARO N.,VERMYLEN J.: Evidence that Washed Human
Platelets Possess Factor-X Activator Activity.Brit.J.Haematol.36:107,1977.
15. WENSLEY R.T.: General Summary of the Use of FEIBA
in Haemophiliacs with Inhibitors to F VIII. Presentation at the Second Workshop
on Factor VIII Inhibitor Patients,Vienna,1979.
16. HILGARTNER M.W.: Personal communication.
To enroll the confidential, Industry-wide Patient Notification System, call
1-888-UPDATE (1-888-873-2838) Feiba, Prothromplex and Immuno are trademarks
of Baxter AG,Austria. Hyland and Baxter are trademarks of Baxter International,
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